EAPM’s publications are based on a series of multistakeholder expert panels that the organization has held over the past six to seven months. As yesterday (21 June) was the summer solstice, at this precise moment the sun appears directly over the Tropic of Cancer — as far north as it appears in the sky all year — and the sun is clearly shining on EU health policy, with the range of activities ongoing at the moment.
Commission sets date for pharmaceutical legislation proposal
In its pharmaceutical strategy, adopted on 25 November 2020, the European Commission announced that, over the coming years, it would launch several legislative and non-legislative actions. These would include, among others, a revision of the basic pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004). The evaluation will cover the period from 2005 to present (date covering the last fundamental amendments to the directive and regulation).
In particular, it will assess: the extent to which existing measures can still effectively reply to the problems identified within the pharmaceutical strategy, also taking into account the international context and regulatory developments globally; the coherence and complementarity with other related pieces of legislation, including those on medical devices, medicines for children and rare diseases, the proposal for the European health data space, and the EU blood, tissues and cells legislation; the mechanisms for the continuous and timely adaptation of technical requirements in light of emerging science and technologies, as well as potential administrative burden and complexity linked to the implementation of this legislation.
According to the Commission, the revision of the general pharmaceutical legal framework aims to ensure access to affordable medicines in the EU; foster innovation, including in areas of unmet medical need (such as in antimicrobials); and enhance supply security while adapting to new scientific and technological developments and reducing regulatory burden where possible.
Drawing lessons from the Covid-19 pandemic, it will support a future-proof and crisis-resistant pharmaceuticals system. The roadmap/inception impact assessment was published on 30 March 2021. A feedback period closed on 27 April 2021.
This was followed by a public consultation for citizens and stakeholders launched on 28 September 2021 (consultation period till 21 December 2021).
According to the Commission work programme for 2022, published on 19 October 2021, the initiative would be put forward on 21 December 2022.
EAPM will publish an article on the above.
New EU rules to ensure safety of medical devices
Ranging from simple contact lenses and sticking plasters to sophisticated pacemakers and hip replacements, medical devices and in vitro diagnostic medical devices are important to our health and quality of life. People rely on these devices every day and expect them to be safe and incorporate the latest progress in science and innovation. The current rules on the safety and performance of medical devices in the EU were harmonized in the 1990s. To reflect the substantial technological and scientific progress in this sector over the last 20 years, the Commission proposed to update the rules to improve the safety of medical devices for EU citizens, create the conditions to modernise the sector and to consolidate its role as a global leader.
Problems with diverging interpretation of the existing rules as well as certain incidents -e.g. with breast implants and metal hips – highlighted the weaknesses of the current legal system and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. To address this, the Commission proposed two Regulations on medical devices and in vitro diagnostic medical devices in 2012. To ensure harmonised application of the rules throughout the EU, the two new Regulations will replace the three existing Directives on medical devices. The new rules significantly tighten the controls to ensure that medical devices are safe and effective and at the same time foster innovation and improve the competitiveness of the medical device sector.
However, a backlog in the applications to bring medical devices up to date with regulations risks causing shortages, health ministers have warned.
EAPM will publish an article on the above.
EU cancer screening extended to lung and gastric cancer (we hope!!)
Although Europe represents less than 10% of the world’s population, it accounts for a quarter of all cancer cases, and cancer in Europe is the second leading cause of death, right after cardiovascular disorders. Europe’s Beating Cancer Plan was approved in plenary last February and translates the European Parliament’s position on crucial issues to be addressed in order to beat cancer, namely cancer prevention, equal access to cancer care across borders, and a clear European approach addressing medicine shortages. It is known that 40-50% of deaths by cancer could be avoided, and that around 50% are influenced by unknown factors, which means that we do not have a whole and clear picture of this matter.
In Europe’s Beating Cancer Plan, the Commission announced a new cancer screening scheme aiming to help EU countries ensure that 90% of the EU population who qualify for breast, cervical and colorectal cancer screenings are offered screening by 2025. It is time to deliver.
As per the draft recommendation, testing for lung cancer is proposed for former and current heavy smokers aged between 50 to 75 years old. They must have smoked the equivalent of 20 cigarettes per day for 30 years, and either still be smoking, or have quit within the past 15 years.
This was a key issue that EAPM has advocated since 2017 during the Maltese Presidency of the EU.